SALT LAKE CITY, June 27, 2018 (GLOBE NEWSWIRE) — PolarityTE, Inc. (Nasdaq:COOL) today announced that the Company hosted a successful meeting of key opinion leaders in New York City on June 25, 2018, addressing the use of SkinTE™ in complex wounds requiring cutaneous reconstruction. The three medical providers who presented at the event discussed the standard of care, limitations in the field, and their use of SkinTE, including patient outcomes and ongoing cases. The presentations emphasized the challenging nature of many of the complex wounds treated, and the encouraging and positive healing observed to date.
The Company’s primary focus is on transforming the lives of patients by discovering, designing and developing a range of regenerative cell and tissue-derived products that have the potential to significantly impact patient quality of life.
The Company also wishes to address certain statements made in an opinion piece published by a short seller to coincide with the KOL summit.
Regarding online statements about a “non-final rejection” and a “final rejection” notice from the USPTO, the Company notes that such statements refer to the receipt of office actions from the USPTO. Office actions are part of the normal patent prosecution process, and are received on the “notification date” identified on each office action. The Company is actively pursuing a variety of claims within multiple published non-provisional patent applications in the U.S. The prosecution dialogue between an applicant and the USPTO commonly includes a series of office actions as well as the applicant’s responses to such office actions. It is common for a first office action to be referred to as a “non-final rejection,” and for a second office action to be referred to as a “final rejection.” Importantly, however, in each such instance the applicant has the opportunity to respond to the USPTO, as well as to continue prosecution thereafter. The Company recently received a second office action on one published patent application and is moving forward with a timely response. The process of patent prosecution before the USPTO can be lengthy. However, the Company does not feel that lack of issued patents should deprive patients of the very real potential benefits they can receive from our products in the interim.
Material Information about the Company’s intellectual property and risks related to obtaining patent protection are disclosed in our SEC filings and reports. The Company has highlighted repeatedly throughout our SEC filings and reports that we have applied for patent protection, that we do not own any issued patents on our technology, and that we rely on protecting our processes and technologies by seeking patent protection as well as by maintaining certain aspects as trade secrets. Our objective is to build a portfolio of patents, in conjunction with the continued protection of our trade secrets and know-how, in order to further protect our regenerative medicine platform and derivative technologies, as well as the manufacturing and deployment processes of those technologies.
S-8 Registration Statement
The Company strongly disputes any claim that any current directors or officers have sold shares of the Company’s stock in the last 12 months. These contentions are a mischaracterization of basic SEC registration practice. Registration of the securities issuable under an incentive stock plan is a routine event and does not equate to a sale of shares. The Company filed a registration statement on Form S-8 with the SEC on May 29, 2018, which covers shares and options granted to its current and former employees and directors under the Company’s incentive stock plan. The filing of a Form S-8 is a customary practice for publicly-held companies. None of the current officers and directors of the Company have sold shares. As is well known, directors, officers, and certain other insiders or affiliates are generally required to publicly report such sales within two days of sale. In addition, as the Company previously reported, its officers and directors continue to be subject to lock-up agreements that prohibit them from selling any shares until September 2018.
Shareholders and Other Companies
With respect to any statements regarding matters involving any of the Company’s shareholders, the Company relies upon the accuracy of SEC filings made by its shareholders. The Company does not comment on matters involving other companies.
The Company believes that there is strong momentum in the business and looks forward to sharing additional information about expected positive outcomes with SkinTE, and the ongoing development of the Company’s pipeline.
PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. The PolarityTE platform technology begins with a small piece of the patient’s own, or autologous, healthy tissue, rather than artificially manipulated individual cells. From this small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to enhance and stimulate the patient’s own cells to regenerate the target tissues. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures with the patient’s own tissue and uses the patient’s own body to support the regenerative process to create the same tissue from which it was derived. PolarityTE’s innovative method is intended to promote and accelerate growth of the patient’s tissues to undergo a form of effective regenerative healing.
SkinTE is intended to be used by physicians or other appropriate healthcare providers for homologous uses of skin tissues/integument. Patients who have suffered from an event, disease, process or acquired deficit that results in the functional loss or void of skin/integument systems can receive SkinTE as an adjunct and/or in place of split-thickness skin grafting, full-thickness grafting, temporizing skin coverage and/or skin substitute products.
SkinTE is for autologous use only. Aseptic technique during harvest and deployment of SkinTE is mandatory.
SkinTE is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.
Forward Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “intend,” “plan,” “will,” “would,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law. Our actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov).
POLARITYTE, the POLARITYTE logo, and SKINTE are all trademarks or registered trademarks of PolarityTE, Inc.
VP of IR & Corporate Strategy
LifeSci Advisors, LLC
Russo Partners LLC
Source: PolarityTE, Inc.